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Regulation - Drug Filing

Zymeworks, a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the achievement of a new development milestone in its collaboration with Eli Lilly and Company (“Lilly”).

Ocular Therapeutix is seeking approval from the US Food and Drug Administration (FDA) for Dextenza (dexamethasone ophthalmic insert) to expand the current indication to include the treatment of ocular inflammation following ophthalmic surgery.

Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec-xxxx), which was formerly known as AVXS-101, has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA) Type 1.

AstraZeneca’s respiratory biologic Fasenra (benralizumab) has secured the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).

GlaxoSmithKline (GSK) has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for an additional indication for Nucala (mepolizumab) as an add-on treatment for severe eosinophilic asthma in paediatric patients aged six to 11 years.

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted two Type II variation applications to the European Medicines Agency (EMA) regarding approval for the expanded use of IMBRUVICA (ibrutinib).